PVAD IQ

by Ultrasight  · Based in United States →Empowering Cardiac Ultrasound With AI
Cardiology Critical Care

Contact for pricing
Regulatory Status Disclosed

Overview

PVAD IQ is an FDA-cleared, AI-enabled imaging tool developed by UltraSight, a leader in AI-guided cardiac imaging workflows. It is designed to strengthen and standardize bedside pump position assessment for patients on microaxial flow pumps. Integrated with the UltraSight Echosystem, PVAD IQ provides real-time, AI-guided focused cardiac ultrasound (FoCUS) that empowers a wider range of healthcare providers, including those without prior sonography experience, to acquire diagnostic-quality images under qualified physician oversight. The tool features a machine-learning algorithm that automatically detects the aortic valve plane and pump inlet, calculating the linear distance between them using transthoracic echocardiography, delivering expert-level accuracy and reduced variability in measurements.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Real-time AI guidance for cardiac ultrasound
  • Quality meter for image acquisition
  • Automatic guidance to optimal cardiac views
  • Compatibility with various ultrasound systems (handheld, laptop, cart-based)
  • Automated detection of aortic valve plane and pump inlet
  • Calculates linear distance between aortic valve plane and pump inlet
  • Expert-level accuracy in pump depth assessment
  • Reduced variability in measurements
  • Enables non-expert medical professionals to acquire diagnostic-quality images
  • Supports 10 standard 2D-TTE cardiac views

Use Cases

  • Assessing pump position and cardiac function in patients with microaxial flow pumps
  • Expediting triage and accelerating clinical decision-making in cardiac care
  • Expanding the effective imaging workforce for cardiac ultrasound
  • Decentralized cardiac ultrasound monitoring for out-of-hospital care
  • Point-of-care cardiac ultrasound in emergency medicine
  • Cardiac imaging in critical care environments

What Physicians Need to Know

Echocardiography AI Features
PVAD IQ is an AI-enabled imaging tool integrated with the UltraSight Echosystem, providing real-time, AI-guided focused cardiac ultrasound (FoCUS). It empowers a wider range of healthcare providers, including non-sonographers, to acquire diagnostic-quality images for assessing microaxial flow pump position and cardiac function. The system offers real-time guidance with a quality meter and automatic direction to optimal views, supporting the acquisition of 10 standard echocardiographic views. Clinical validation demonstrates expert-level accuracy in calculating pump depth with a Mean Absolute Error (MAE) of 0.42 cm and reduced variability compared to inter-observer variability among cardiologists. Studies also indicate high accuracy for assessing left ventricular size (99.2%), left ventricular function (99.6%), right ventricular size (93%), and presence of significant pericardial effusion (100%) by novice users.
Heart Failure Risk Prediction
The UltraSight Echosystem, which includes PVAD IQ, has demonstrated feasibility and accuracy in detecting Stage B heart failure by novice users, achieving 95% interpretability in AI-assisted scans for asymptomatic left ventricular dilation and reduced LVEF. The AI platform showed a 95% negative predictive value for identifying patients with LVEF below 50%.
Cardiac Monitoring Integration
PVAD IQ is specifically designed to support the management of patients on microaxial flow pumps in critical care settings, enabling consistent, rapid bedside echocardiography for pump position assessment and cardiac function. The broader UltraSight platform aims to increase access to cardiac monitoring for chronic heart disease patients and those requiring consistent follow-up.
Real-Time Alert Capability
The UltraSight software, which PVAD IQ is part of, provides continuous real-time guidance and movement tracking. It offers detailed, specific, and responsive instructions to the user on how to maneuver the ultrasound probe and indicates when a diagnostic quality image has been obtained by meeting a quality threshold.
ECG/EKG Analysis Capability
The UltraSight Echosystem has been studied in combination with AI-enabled electrocardiography (AI-ECG) for screening structural heart disease. This combination significantly increased the positive predictive value (PPV) for identifying reduced left ventricular ejection fraction (LVEF) or significant aortic valve disease.
Physician Tip

PVAD IQ offers a critical tool for managing patients with microaxial flow pumps, providing objective, AI-guided assessment of pump position and cardiac function at the bedside. Its ability to enable non-expert clinicians to acquire diagnostic-quality echocardiograms can significantly enhance access to timely cardiac imaging in critical care settings, reducing reliance on sonographer availability and accelerating clinical decision-making. Physicians can leverage this tool to standardize pump management protocols, improve coordination across care teams (interventional cardiology, heart failure, critical care), and gain clarity and confidence in complex cardiac cases.

PVAD IQ is an integral part of the UltraSight Echo Stewardship System. The UltraSight AI guidance software is designed to pair with existing point-of-care ultrasound (PoCUS) devices and has expanded compatibility across various ultrasound system types, including handheld, laptop, and cart-based systems. Collaborations with ultrasound device manufacturers like Philips Lumify and Butterfly Network (Butterfly iQ/iQ3) are in place for the broader UltraSight platform, indicating a flexible and adaptable integration strategy within diverse clinical environments. UltraSight also collaborates with institutions like Mayo Clinic for algorithm development.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentSoftware accessory for compatible general-purpose diagnostic ultrasound systems (e.g., Philips Lumify S4-1 ultrasound transducer).
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

PVAD IQ received FDA clearance as a new addition to UltraSight's Echo Stewardship System, designed to support the growing clinical demands of patients on microaxial flow pumps. It is intended for non-invasive analysis of ultrasound images to detect and measure structures from cardiac ultrasound in adult patients with Percutaneous Ventricular Assist Devices (PVAD).

Integrations
EHR Not specified
Specialties Cardiology, Critical Care

What the Web Says

PVAD IQ is an FDA-cleared, AI-enabled imaging tool developed by UltraSight, designed to standardize and strengthen bedside pump position assessment for Percutaneous Ventricular Assist Devices (PVADs) using transthoracic echocardiography (TTE). It integrates with the UltraSight Echosystem to provide real-time, AI-guided focused cardiac ultrasound (FoCUS), enabling a wider range of healthcare providers to acquire diagnostic-quality images. Clinical validation indicates that the algorithm calculates pump depth with expert-level accuracy and reduced variability compared to inter-observer variability among cardiologists.

Overall: Positive

Strengths

  • Expert-level accuracy in calculating pump depth, comparable to expert cardiologists.
  • Reduced variability in measurements compared to inter-observer variability between cardiologists.
  • Standardizes a technically demanding measurement, leading to consistent and rapid imaging.
  • Empowers a wider range of healthcare providers, including novice ultrasound users, to acquire diagnostic-quality cardiac images after minimal training.
  • Provides real-time, AI-guided focused cardiac ultrasound.
  • FDA-cleared device for clinical use.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra regarding PVAD IQ itself. The search results for 'IQ' on Reddit, G2, and Capterra primarily pertained to general IQ tests, other software named 'IQ' (e.g., Plate IQ, Operative IQ, CaptivateIQ, ReviewIQ, Health IQ, pack IQ, PDQ.com), or general healthcare IT reviews, and not UltraSight's PVAD IQ.

Based on reviews from: Cardiac Critical Care - UltraSight, New Study Reveals UltraSightu00ae & Sheba Medical Center Enable Novice Ultrasound Users to Obtain Accurate, Diagnostic Quality Cardiac Images, New Landmark Study Indicates UltraSight Enables Novice Ultrasound Users to Capture High Quality Cardiac Images, accessdata.fda.gov, Indeed.com, TrustRadius, Reddit, AuntMinnie, Capterra

Last updated: 2026-07-21

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Press & Coverage

UltraSight
UltraSightu00ae PVAD IQ Achieves Expert-Level Accuracy, Data Presented as Late-Breaking at THT 2026
UltraSight's PVAD IQu2122 software demonstrated expert-level accuracy in a late-breaking clinical study presented at the THT 2026 conference, designed to assist healthcare providers in managing patients with microaxial flow pumps. The AI-powered tool aims to standardize pump depth assessment and reduce variability in critical care settings.
2026-03
UltraSight
UltraSight Advances AI-Enabled Workflows in Cardiac Critical Care
UltraSight announced FDA clearance for PVAD IQu2122, an imaging tool integrated with its Echo Stewardship Platform to support echocardiography in managing patients with microaxial flow pumps. This AI-enabled tool aims to improve access to consistent, rapid bedside echocardiography for pump position assessment.
2026-02
UltraSight
UltraSightu00ae Receives FDA Clearance to Expand Its AI-Guided Cardiac Echo Stewardship Platform Across Ultrasound Systems
UltraSight received FDA clearance to expand its Echo Stewardship Platform, allowing compatibility with various ultrasound systems, including handheld, laptop, and cart-based devices. This expansion aims to scale AI-guided focused cardiac ultrasound (FoCUS) across existing healthcare equipment.
2026-01
ResearchGate
Evaluating Transparency of Predetermined Change Control Plans in FDA-Cleared Radiology AI Devices: A Systematic Scoping Review
A systematic review evaluating the transparency of Predetermined Change Control Plans (PCCP) in FDA-cleared radiology AI devices listed UltraSight Ltd.'s PVAD IQ Software with a clearance date of December 18, 2025. The review assessed PCCP adoption and documentation completeness across AI/ML-enabled devices.
2026-04
DAIC (Diagnostic and Interventional Cardiology)
AI-Powered Software Helps Facilitate Expert-Level Microaxial Flow Pump Assessment
UltraSight's PVAD IQ, an FDA-cleared AI-powered software, achieved expert-level accuracy in a clinical study presented at THT 2026, designed to help healthcare providers manage patients with microaxial flow pumps. The software uses machine learning algorithms to analyze ultrasound clips and measure structures for correct PVAD placement.
2026-03
UltraSight
UltraSight Receives KFDA Regulatory Approval for AI Guidance System, Expanding Global Access to Cardiac Imaging
UltraSight announced that its real-time machine learning guidance software received regulatory approval from South Korea's Ministry of Food and Drug Safety (KFDA). This approval expands global access to UltraSight's AI-driven cardiac imaging software.
2025-06
UltraSight
JACEP Open Publication Demonstrates Economic Benefits to Healthcare Systems with AI-Guided TTE-First Strategies
New findings published in the Journal of the American College of Emergency Physicians Open (JACEP Open) highlight the potential for significant healthcare system benefits and cost savings from broader adoption of AI-guided focused transthoracic echocardiograms (TTEs) at the bedside.
2025-04
UltraSight
FDA Grants Clearance for UltraSight's AI-Powered Cardiac Ultrasound Technology
UltraSight received FDA clearance for its AI-powered ultrasound guidance software, which aims to enable more medical professionals to conduct cardiac ultrasounds in various care settings and expand patient access to cardiac imaging.
2023-07

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Frequently Asked Questions

PVAD IQ is an FDA-cleared, AI-powered software designed to integrate into existing ultrasound workflows as part of UltraSight's Echosystem. Its primary function is to analyze ultrasound clips to automatically detect the aortic valve plane and pump inlet, calculating the insertion depth of microaxial flow pumps (PVADs). This standardization aims to reduce variability in pump depth assessment, support faster bedside decisions, and extend expert-level assessment across care teams.
PVAD IQ is an FDA-cleared Software as a Medical Device (SaMD), indicating it has met regulatory standards for safety and effectiveness. While specific details on data privacy and security protocols were not extensively detailed in the provided search results, as a medical device handling sensitive patient data, it would be subject to stringent healthcare data privacy regulations like HIPAA in the US.
PVAD IQ is intended for clinical decision support by a qualified physician, meaning it assists rather than replaces expert judgment. While it standardizes measurements and reduces variability, physicians must still oversee and interpret the AI-driven assessments in the context of the patient's overall clinical picture. The system's performance has been validated with a mean absolute error of 0.42 cm, comparable to expert intra-observer consistency.
The primary alternative to using PVAD IQ is the traditional manual assessment of PVAD positioning and depth using transthoracic echocardiography performed by expert cardiologists. This manual method, however, is noted to be technically demanding and highly operator-dependent, leading to potential variability in measurements. Currently, direct, equivalent AI-powered alternatives specifically for real-time PVAD depth assessment were not identified in the search results.
Specific pricing information for UltraSight's PVAD IQ is not publicly available in the provided search results. Typically, pricing for specialized medical AI software like PVAD IQ involves direct inquiry with the vendor, UltraSight, and may depend on factors such as institutional size, integration needs, and licensing models. It is common for such solutions to be offered through subscription plans or enterprise agreements.
PVAD IQ's AI algorithm has demonstrated expert-level accuracy and reduced variability in assessing PVAD positioning. Clinical validation studies showed a mean absolute error of 0.42 cm, meeting pre-specified performance goals and performing comparably to the intra-observer consistency of expert readers. This suggests a high degree of reliability in standardizing a technically demanding measurement.
While specific details on training and technical support were not explicitly outlined, as an AI-enabled imaging tool integrated with the UltraSight Echosystem, it is designed to empower a wider range of healthcare providers to acquire diagnostic-quality images. This implies that UltraSight would likely provide comprehensive training and ongoing technical support to ensure proper implementation and utilization in diverse clinical settings.

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Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
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